Postoperative Acute Pain
Conditions
Keywords
postoperative acute pain, laparoscopic hepatectomy, Anrikefon
Brief summary
A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.
Detailed description
A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.
Interventions
DRUGAnruikefon 1 μg/kg per dose Group
Anruikefon 1 μg/kg/dose, once every 8 hours (q8h), for a total of 6 doses.
DRUGAnruikefon 100 μg per dose Group
Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.
DRUGControl group
0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥ 18 years; * American Society of Anesthesiologists (ASA) physical status classification I-III; * Body mass index (BMI): 18 kg/m² ≤ BMI ≤ 30 kg/m²; * Patients scheduled to undergo laparoscopic hepatectomy under general anesthesia with estimated operation duration ≤ 5 hours; * Agree to participate in this trial and voluntarily sign the informed consent form.
Exclusion criteria
* Patients with a history of severe cardiopulmonary disease, neuropsychiatric disorders, digestive system diseases, chronic dizziness or vestibular dysfunction; * Patients undergoing emergency surgery or trauma patients; * Intraoperative conversion to open laparotomy; * History of abdominal surgery within the past 3 months; * Patients undergoing liver transplantation or with metastasis to other organs; * Patients requiring synchronous resection of organs other than the gallbladder, extrahepatic bile ducts and intestines due to intraoperative clinical needs; * Severe renal dysfunction (estimated glomerular filtration rate \<30 mL/min/1.73 m²); * Laboratory findings or clinical evaluation indicating hypothyroidism or hypokalemia graded ≥ Grade 3 per CTCAE v6.0; * Subjects who experienced nausea, retching or vomiting within 24 hours before anesthesia induction (excluding those caused by bowel preparation); * Patients expected to require postoperative mechanical ventilation via endotracheal intubation or naso/orogastric tube placement for more than 24 hours; * Known allergy or contraindication to opioids and other anesthetics, antiemetics that may be administered during the trial. * Use of drugs with analgesic, antiemetic or anti-inflammatory effects with unknown half-life within 14 days prior to randomization; or the interval between the last administration and randomization is shorter than 5 half-lives or the duration of drug effect (whichever is longer). Such drugs include, but are not limited to, opioid analgesics, non-opioid analgesics, antiemetics (or drugs with antiemetic properties), sedative-hypnotics, sedative anesthetics, glucocorticoids and other drugs with analgesic or antiemetic effects. * Subjects with any other factors deemed by the investigator(s) to render them unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consumption of sufentanil via PCIA within 48 hours after the first study drug administration | 0-48 hours post first study drug dose |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of rescue analgesia | Within0-24 hours and 0-48 hours after the first study drug administration |
| Cumulative consumption dose of rescue analgesia | within 0-24 hours and 0-48 hours after the first study drug administration |
| Time from end of surgery to first passage of flatus (hours) | Throughout the inpatient hospital stay after surgery, from the end of surgery until the first flatus occurs |
| Time from end of surgery to first defecation (hours) | Throughout the inpatient hospital stay after surgery, from the end of surgery until the first defecation occurs |
| Time from the end of surgery to first ambulation (hours) | Throughout the inpatient hospital stay after surgery, from the end of surgery until the first ambulation occurs |
| Incidence of nausea, vomiting and PONV | Within 48 hours after the first study drug administration |
| Patient satisfaction score for analgesia | Within 48 hours after the first study drug administration |
| Proportion of subjects with resting numerical rating scale (NRS) pain score ≥ 3 | Within 0-24 hours and 0-48 hours after the first study drug administration |
| Resting numerical rating scale (NRS) pain score | At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration |
| Movement-evoked numerical rating scale (NRS) pain score | At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration |
| Incidence of rescue antiemetic treatment | Within 48 hours after the first study drug administration |
| Cumulative dose of rescue antiemetic treatment | Within 48 hours after the first study drug administration |
| Incidence of serious adverse events and study drug-related adverse events | Throughout the inpatient hospital stay after surgery, from the end of surgery until hospital discharge |
| Sleep quality score assessed using the Richards-Campbell Sleep Questionnaire (RCSQ; score range 0-100, higher scores indicate better sleep quality) | On the single night following the first administration of study drug |
| Cumulative consumption of sufentanil delivered via patient-controlled intravenous analgesia (PCIA) | Within 24 hours after the first study-drug administration |
| Serum biomarker concentrations: alanine transaminase (ALT), aspartate transaminase (AST), albumin (ALB), total bilirubin (TBIL), direct bilirubin (DBIL), indirect bilirubin (IBIL), international normalized ratio (INR) | Preoperative baseline (prior to surgical incision), and within the interval from 24 hours to 48 hours after the first administration of study drug |
| Proportion of subjects with movement-evoked Numerical Rating Scale (NRS) pain score ≥ 3 | Within 0-24 hours and 0-48 hours after the first study-drug administration |
| Overall patient recovery quality score evaluated via the QoR-15 questionnaire (score range 0-150; higher scores indicate better recovery quality) | Within 48 hours after the first study-drug administration |
| Cumulative opioid consumption, converted to intravenous morphine milligram equivalents (MME) | Within the interval from 0 hours to 24 hours after the first administration of study drug, and within the interval from 0 hours to 48 hours after the first administration of study drug |
Countries
China
Contacts
CONTACTChangzhen Shang
PRINCIPAL_INVESTIGATORChangzhen Shang
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Outcome results
None listed